Breast CancerMap-totalNCT06347952
Mapping Arterial Perforators Within the Breast During Mammoplasty
An observational study of Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Breast cancer surgery can often be carried out as part of a breast reduction procedure known as 'therapeutic mammoplasty'. Where a woman has a breast with adequate volume, even larger cancers can be removed in an aesthetically acceptable way with re-shaping of the breast (often reduction and lift) incorporated into… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Use of Acoustic and color imaging doppler during surgery for breast cancer
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Apr 2022to 29 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A prospective single-centre cohort study on consecutive patients diagnosed with primary breast cancer undergoing either therapeutic or symmetrising mammoplasty (Wise or vertical scar pattern) or both. Inclusion criteria were female patients >18 years age and plan for construction of at least 1 (i.e. unilateral / bilateral) NAC pedicle based on the superficial branches of either the 2nd (superior), 3rd (medial) anterior intercostal, the lateral thoracic (lateral) arteries or a combination thereof.
Who may be able to join
- female patients >18 years age
- plan for construction of at least 1 (i.e. unilateral / bilateral) NAC pedicle based on the superficial branches of either the 2nd (superior), 3rd (medial) anterior intercostal, the lateral thoracic (lateral) arteries or a combination thereof.
Who cannot join
- Patients planned solely for inferior NAC pedicle reduction mammoplasty
- patients planned for bilateral nipple/NAC sacrifice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mapping Arterial Perforators of the Nipple Areolar Complex and the Horizontal Septum During Mammoplasty
Breast cancer surgery can often be carried out as part of a breast reduction procedure known as 'therapeutic mammoplasty'. Where a woman has a breast with adequate volume, even larger cancers can be removed in an aesthetically acceptable way with re-shaping of the breast (often reduction and lift) incorporated into the cancer removal. An expectation and desire for most women is that the nipple and areola (known as the 'nipple-areolar complex' or NAC) is not only preserved, but re-positioned (usually lifted) to re-balance the overall aesthetic result.
In moving the NAC, the surgeon must ensure an adequate blood supply is maintained to preserve nourishment of the NAC tissue otherwise it can die (necrose) resulting in its removal. The tissue carrying the blood supply is known as a 'pedicle' and is fashioned by the surgeon for each patient during surgery.
Read more
We know as surgeons, that in most areas of anatomy of the human body there are variations in the pattern of blood vessels. The NAC blood supply is no exception. Yet for each individual patient, the only way to safely know these anatomical patterns is to map them before or during surgery.
A surgical tool utilising an aspect of ultrasound (known as doppler) is often used to locate visually (or by hearing) blood flow from blood vessels in operations where such knowledge is critical to the success of the procedure (for example DIEP-based breast reconstruction or chest wall perforator flaps).
We would like to evaluate the effectiveness of the routine use of doppler for NAC preservation during mammoplasty procedures to see if it gives the consultant surgeon and/or trainee a greater degree of confidence when shaping the NAC pedicle to preserve its blood supply.
In addition, we evaluate the training potential of patients undergoing symmetrising breast reduction, whereby the tissue removed is first mapped using acoustic doppler as for the NAC above.
Read the detailed description
Despite breast cancer being one of the most frequent affecting women worldwide, it is also one of the most curable. Its multimodality treatment is based on surgery, radiotherapy and systemic therapy.
Breast conservation has evolved thanks to the utilization of mammoplasty techniques to achieve better aesthetic results - known collectively as 'oncoplastic' when applied to cancer surgery.
The key considerations in oncoplastic surgery are: tumour characteristics (extent, location) and reconstituting the aesthetically acceptable breast shape as well as nipple-areola complex (NAC) preservation. The former is vital to achieve clear resection margins to optimise local control. Planning is aided by imaging with ultrasound, mammography and often MRI. NAC preservation is a priority and expectation of patients and surgeons alike developed in the field of aesthetic breast surgery by plastic surgeons.
The attachment of any structure to the body by its nourishing blood supply (arteries and veins) is known as a 'pedicle'. The anatomy of the pedicle and its preservation is key to preservation of the NAC which has a well understood blood supply albeit with variations across patients and well-described patterns (ref). To preserve the NAC as part of a cancer resection and aesthetic breast re-shaping, a pedicle must be fashioned and the NAC successfully re-positioned to restore the aesthetic balance of the newly shaped (and often lifted) breast.
The aim of this study is to determine if by use of doppler (acoustic or colour flow modalities) to map the blood vessels supplying the NAC (for each individual patient), surgeons and trainees can construct a safe pedicle with greater confidence and ease, reducing the concern about diminishing its blood supply which could lead to NAC necrosis and loss. We would like to study the nipple blood supply as it pertains to each patient before surgery using acoustic doppler (AD) and colour doppler imaging (CDI). Each modality has its strengths and weaknesses and this evaluation aims to assess the contribution of each.
The most challenging part of therapeutic mammoplasty is the pre-operative planning. The surgeon must consider (1) localization of the tumour location and extent, (2) re-shaping of the remaining breast parenchyma and (3) placement of the vascularized the NAC and pedicle.
Several studies have been done regarding NAC vascularization and its variation between not only each person, but also each side (right versus left). Most studies were on cadavers3, MRI 4or CT angiography5. On the other hand, Seitz et al6 pointed out the predominancy of the NAC vascularization based on preoperative MRI in the breast without cancer. Specifically, they split all 56 breasts into 5 categories: type I medial, type II lateral, type III central, type IV inferior, and type V mixed. Moreover, they highlighted that the majority of NACs were supplied mostly by medial vessels. Basaran et al7 evaluated sixteen patients with severe gigantomastia and they marked the vessel locations before surgery by using Doppler ultrasonography.
Given the variation between people and their breasts, in this SE we would like to map preoperatively the NAC vascularization to understand if it could assist the surgeon's plan or even enable them to modify the NAC pedicle design. The mapping will be done by both CDI and AC. We will use both techniques to understand if there will be any difference in their accuracy and to determine if 1 modality alone will suffice.
Whilst both methods (acoustic and colour flow doppler) are used selectively in cases by some surgeons, this SE will specifically if routine use incorporated into the procedure will systematically facilitate pedicle design. The doppler carries no risk to the patient and is considered a tool to facilitate surgery rather than an intervention beyond standard of care.
Specifically, acoustic doppler (AC) - is a hand-held device, easy to use intra-operatively which gives an audible signal in real-time to enable marking of the exact location of a blood vessel at a given point (or along a specified line) within the tissue / under the skin.
Colour doppler imaging (CDI) will additionally give visual information which includes the calibre and depth of the vessel and enables the entire course of the vessel and any connections to be mapped relatively easily.
In reality, when the design and shaping of the NAC pedicle is undertaken during the operation, ideal placement / movement of this structure may be restricted by the surrounding tissue attachments which the surgeon may be fearful of dividing in case a critical artery is divided in the process (compromising the NAC perfusion). Knowing the exact location of the artery will give the surgeon confidence in knowing how far such tissue mobilisation can be safely undertaken.
Some therapeutic mammoplasties also involve creation of a 'secondary pedicle' which consists of breast tissue - again mobilised on a pedicle which must be moved within the breast to fill a defect created by the cancer resection. A secondary aim of this SE will be to map the principle arteries which supply that tissue as well.
In summary, this SE aims to establish the benefits of an ad-hoc practice by careful documentation of consecutive cases prospectively during surgery for mammoplasty where NAC or secondary pedicle mobilisation is required.
- Conditions
- Breast Cancer
- Being tested
- Use of Acoustic and color imaging doppler during surgery for breast cancer
- Keywords
- oncoplastic surgery, therapeutic mammoplasty, breast reduction for cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Acoustic and color imaging doppler during surgery for breast cancerProcedure or surgery
The intervention (post pilot study) is to systematically record the effect of routine use of acoustic as well as color imaging doppler during mammoplasty for breast cancer (for both the therapeutic and symmetrising breast reduction).
What is being measured
The primary outcome is the main question the study is designed to answer.
Full-thickness (complete or partial) necrosis of nipple-areolar complex
Any amount (as witnessed clinically) of full-thickness necrosis of the nipple-areolar complex of either breast in patients who have undergone breast reduction (for cancer - on the cancer side or matching reduction side)
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start27 Apr 2022
- Primary completion25 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter A Barry, MPhil, FRACS, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347952
- Sponsor's protocol ID
- SE1188
- Acronym
- Map-total
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Arterial Perforators of the Nipple Areolar Complex and the Horizontal Septum During Mammoplasty
- ClinicalTrials.gov ID
- NCT06347952
- Acronym / sponsor ID
- Map-total / SE1188
- Conditions
- Breast Cancer
- Keywords
- oncoplastic surgery, therapeutic mammoplasty, breast reduction for cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer surgery can often be carried out as part of a breast reduction procedure known as 'therapeutic mammoplasty'. Where a woman has a breast with adequate volume, even larger cancers can be removed in an aesthetically acceptable way with re-shaping of the breast (often reduction and lift) incorporated into the cancer removal. An expectation and desire for most women is that the nipple and areola (known as the 'nipple-areolar complex' or NAC) is not only preserved, but re-positioned (usually lifted) to re-balance the overall aesthetic result.
In moving the NAC, the surgeon must ensure an adequate blood supply is maintained to preserve nourishment of the NAC tissue otherwise it can die (necrose) resulting in its removal. The tissue carrying the blood supply is known as a 'pedicle' and is fashioned by the surgeon for each patient during surgery.
We know as surgeons, that in most areas of anatomy of the human body there are variations in the pattern of blood vessels. The NAC blood supply is no exception. Yet for each individual patient, the only way to safely know these anatomical patterns is to map them before or during surgery.
A surgical tool utilising an aspect of ultrasound (known as doppler) is often used to locate visually (or by hearing) blood flow from blood vessels in operations where such knowledge is critical to the success of the procedure (for example DIEP-based breast reconstruction or chest wall perforator flaps).
We would like to evaluate the effectiveness of the routine use of doppler for NAC preservation during mammoplasty procedures to see if it gives the consultant surgeon and/or trainee a greater degree of confidence when shaping the NAC pedicle to preserve its blood supply.
In addition, we evaluate the training potential of patients undergoing symmetrising breast reduction, whereby the tissue removed is first mapped using acoustic doppler as for the NAC above.
Detailed description
Despite breast cancer being one of the most frequent affecting women worldwide, it is also one of the most curable. Its multimodality treatment is based on surgery, radiotherapy and systemic therapy.
Breast conservation has evolved thanks to the utilization of mammoplasty techniques to achieve better aesthetic results - known collectively as 'oncoplastic' when applied to cancer surgery.
The key considerations in oncoplastic surgery are: tumour characteristics (extent, location) and reconstituting the aesthetically acceptable breast shape as well as nipple-areola complex (NAC) preservation. The former is vital to achieve clear resection margins to optimise local control. Planning is aided by imaging with ultrasound, mammography and often MRI. NAC preservation is a priority and expectation of patients and surgeons alike developed in the field of aesthetic breast surgery by plastic surgeons.
The attachment of any structure to the body by its nourishing blood supply (arteries and veins) is known as a 'pedicle'. The anatomy of the pedicle and its preservation is key to preservation of the NAC which has a well understood blood supply albeit with variations across patients and well-described patterns (ref). To preserve the NAC as part of a cancer resection and aesthetic breast re-shaping, a pedicle must be fashioned and the NAC successfully re-positioned to restore the aesthetic balance of the newly shaped (and often lifted) breast.
The aim of this study is to determine if by use of doppler (acoustic or colour flow modalities) to map the blood vessels supplying the NAC (for each individual patient), surgeons and trainees can construct a safe pedicle with greater confidence and ease, reducing the concern about diminishing its blood supply which could lead to NAC necrosis and loss. We would like to study the nipple blood supply as it pertains to each patient before surgery using acoustic doppler (AD) and colour doppler imaging (CDI). Each modality has its strengths and weaknesses and this evaluation aims to assess the contribution of each.
The most challenging part of therapeutic mammoplasty is the pre-operative planning. The surgeon must consider (1) localization of the tumour location and extent, (2) re-shaping of the remaining breast parenchyma and (3) placement of the vascularized the NAC and pedicle.
Several studies have been done regarding NAC vascularization and its variation between not only each person, but also each side (right versus left). Most studies were on cadavers3, MRI 4or CT angiography5. On the other hand, Seitz et al6 pointed out the predominancy of the NAC vascularization based on preoperative MRI in the breast without cancer. Specifically, they split all 56 breasts into 5 categories: type I medial, type II lateral, type III central, type IV inferior, and type V mixed. Moreover, they highlighted that the majority of NACs were supplied mostly by medial vessels. Basaran et al7 evaluated sixteen patients with severe gigantomastia and they marked the vessel locations before surgery by using Doppler ultrasonography.
Given the variation between people and their breasts, in this SE we would like to map preoperatively the NAC vascularization to understand if it could assist the surgeon's plan or even enable them to modify the NAC pedicle design. The mapping will be done by both CDI and AC. We will use both techniques to understand if there will be any difference in their accuracy and to determine if 1 modality alone will suffice.
Whilst both methods (acoustic and colour flow doppler) are used selectively in cases by some surgeons, this SE will specifically if routine use incorporated into the procedure will systematically facilitate pedicle design. The doppler carries no risk to the patient and is considered a tool to facilitate surgery rather than an intervention beyond standard of care.
Specifically, acoustic doppler (AC) - is a hand-held device, easy to use intra-operatively which gives an audible signal in real-time to enable marking of the exact location of a blood vessel at a given point (or along a specified line) within the tissue / under the skin.
Colour doppler imaging (CDI) will additionally give visual information which includes the calibre and depth of the vessel and enables the entire course of the vessel and any connections to be mapped relatively easily.
In reality, when the design and shaping of the NAC pedicle is undertaken during the operation, ideal placement / movement of this structure may be restricted by the surrounding tissue attachments which the surgeon may be fearful of dividing in case a critical artery is divided in the process (compromising the NAC perfusion). Knowing the exact location of the artery will give the surgeon confidence in knowing how far such tissue mobilisation can be safely undertaken.
Some therapeutic mammoplasties also involve creation of a 'secondary pedicle' which consists of breast tissue - again mobilised on a pedicle which must be moved within the breast to fill a defect created by the cancer resection. A secondary aim of this SE will be to map the principle arteries which supply that tissue as well.
In summary, this SE aims to establish the benefits of an ad-hoc practice by careful documentation of consecutive cases prospectively during surgery for mammoplasty where NAC or secondary pedicle mobilisation is required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective single-centre cohort study on consecutive patients diagnosed with primary breast cancer undergoing either therapeutic or symmetrising mammoplasty (Wise or vertical scar pattern) or both. Inclusion criteria were female patients >18 years age and plan for construction of at least 1 (i.e. unilateral / bilateral) NAC pedicle based on the superficial branches of either the 2nd (superior), 3rd (medial) anterior intercostal, the lateral thoracic (lateral) arteries or a combination thereof.
Key inclusion criteria (2 listed)
- female patients >18 years age
- plan for construction of at least 1 (i.e. unilateral / bilateral) NAC pedicle based on the superficial branches of either the 2nd (superior), 3rd (medial) anterior intercostal, the lateral thoracic (lateral) arteries or a combination thereof.
Key exclusion criteria (2 listed)
- Patients planned solely for inferior NAC pedicle reduction mammoplasty
- patients planned for bilateral nipple/NAC sacrifice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Acoustic and color imaging doppler during surgery for breast cancerThe intervention (post pilot study) is to systematically record the effect of routine use of acoustic as well as color imaging doppler during mammoplasty for breast cancer (for both the therapeutic and symmetrising breast reduction). | Procedure or surgery | – |
Primary outcome
Full-thickness (complete or partial) necrosis of nipple-areolar complex
Time frame: Within 30 days after surgery
Any amount (as witnessed clinically) of full-thickness necrosis of the nipple-areolar complex of either breast in patients who have undergone breast reduction (for cancer - on the cancer side or matching reduction side)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A Barry, MPhil, FRACS principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full-thickness (complete or partial) necrosis of nipple-areolar complex (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.